Trial Outcomes & Findings for A Study for Type 2 Diabetic Patients (NCT NCT00548808)
NCT ID: NCT00548808
Last Updated: 2010-09-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
426 participants
Primary outcome timeframe
Baseline, 48 weeks
Results posted on
2010-09-15
Participant Flow
3 patients randomized but did not receive study drug: 1 withdrew, 1 did not want to use insulin, 1 lost to follow-up. Full Analysis Set: randomized, received at least 1 dose of study drug. Per-Protocol Set: randomized; no entry criteria violations; completed \>=32 weeks of study; no systemic glucocorticoid therapy \>14 cumulative days during study.
Participant milestones
| Measure |
Insulin Lispro LM
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Overall Study
STARTED
|
214
|
212
|
|
Overall Study
Full Analysis Set
|
211
|
212
|
|
Overall Study
Per-Protocol Set
|
177
|
184
|
|
Overall Study
COMPLETED
|
172
|
186
|
|
Overall Study
NOT COMPLETED
|
42
|
26
|
Reasons for withdrawal
| Measure |
Insulin Lispro LM
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
|
Overall Study
Protocol Violation
|
8
|
8
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
|
Overall Study
Physician Decision
|
6
|
3
|
|
Overall Study
Adverse Event
|
4
|
5
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Entry Criteria Not Met
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
1
|
Baseline Characteristics
A Study for Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Insulin Lispro LM
n=211 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=212 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
Total
n=423 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
56.68 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
56.29 years
STANDARD_DEVIATION 9.35 • n=7 Participants
|
56.48 years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
8 participants
n=5 Participants
|
16 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
69 participants
n=5 Participants
|
61 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
78 participants
n=5 Participants
|
77 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian (Indian sub-continent)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Region of Enrollment
China
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
India
|
53 participants
n=5 Participants
|
53 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 48 weeksPopulation: Per-protocol set: randomized, no entry criteria violations, completed \>=32 weeks of study, and no systemic glucocorticoid therapy for \>14 cumulative days during study. Last observation carried forward.
Outcome measures
| Measure |
Insulin Lispro LM
n=177 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=184 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)
|
-1.91 percent (%) glycated hemoglobin
Standard Error 0.23
|
-1.87 percent (%) glycated hemoglobin
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Baseline, 16 Weeks, 32 Weeks, 48 WeeksPopulation: Per-protocol set: randomized, no entry criteria violations, completed \>=32 weeks of study, and no systemic glucocorticoid therapy for \>14 cumulative days during study.
Outcome measures
| Measure |
Insulin Lispro LM
n=177 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=184 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) Over Time
16 Week Change from Baseline
|
-1.65 percent (%) glycated hemoglobin
Standard Error 0.23
|
-1.76 percent (%) glycated hemoglobin
Standard Error 0.23
|
|
Change in Hemoglobin A1c (HbA1c) Over Time
32 Week Change from Baseline
|
-1.92 percent (%) glycated hemoglobin
Standard Error 0.23
|
-1.90 percent (%) glycated hemoglobin
Standard Error 0.23
|
|
Change in Hemoglobin A1c (HbA1c) Over Time
48 Week Change from Baseline
|
-1.91 percent (%) glycated hemoglobin
Standard Error 0.23
|
-1.87 percent (%) glycated hemoglobin
Standard Error 0.23
|
SECONDARY outcome
Timeframe: 16 weeks, 32 weeks, 48 weeksPopulation: Per-protocol set: randomized; no entry criteria violations; completed \>=32 weeks of study; no systemic glucocorticoid therapy \>14 cumulative days during study.
Outcome measures
| Measure |
Insulin Lispro LM
n=177 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=184 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Percent achieving HbA1c < 7.0 % at 48 weeks
|
40.0 percentage of participants
|
39.1 percentage of participants
|
|
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Percent achieving HbA1c < 6.5 % at 16 weeks
|
10.2 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Percent achieving HbA1c < 7.0 % at 16 weeks
|
28.2 percentage of participants
|
32.6 percentage of participants
|
|
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Percent achieving HbA1c < 6.5 % at 32 weeks
|
19.4 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Percent achieving HbA1c < 7.0 % at 32 weeks
|
40.6 percentage of participants
|
38.8 percentage of participants
|
|
Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time
Percent achieving HbA1c < 6.5 % at 48 weeks
|
21.2 percentage of participants
|
19.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks, 32 weeks, 48 weeksPopulation: Per-protocol set: randomized; no entry criteria violations; completed \>=32 weeks of study; no systemic glucocorticoid therapy \>14 cumulative days during study.
Outcome measures
| Measure |
Insulin Lispro LM
n=177 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=184 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
7-point Self-monitored Blood Glucose Profiles
Evening Pre-Meal Baseline
|
10.39 millimoles per liter (mmol/L)
Standard Deviation 2.72
|
10.65 millimoles per liter (mmol/L)
Standard Deviation 3.14
|
|
7-point Self-monitored Blood Glucose Profiles
Evening Postprandial Meal Baseline
|
12.59 millimoles per liter (mmol/L)
Standard Deviation 3.09
|
12.80 millimoles per liter (mmol/L)
Standard Deviation 3.64
|
|
7-point Self-monitored Blood Glucose Profiles
0300 Hours Baseline
|
10.09 millimoles per liter (mmol/L)
Standard Deviation 2.82
|
10.12 millimoles per liter (mmol/L)
Standard Deviation 3.03
|
|
7-point Self-monitored Blood Glucose Profiles
Morning Pre-Meal Baseline
|
9.92 millimoles per liter (mmol/L)
Standard Deviation 2.28
|
10.04 millimoles per liter (mmol/L)
Standard Deviation 2.36
|
|
7-point Self-monitored Blood Glucose Profiles
Morning Postprandial Meal Baseline
|
13.64 millimoles per liter (mmol/L)
Standard Deviation 3.13
|
13.70 millimoles per liter (mmol/L)
Standard Deviation 3.42
|
|
7-point Self-monitored Blood Glucose Profiles
Midday Pre-Meal Baseline
|
10.36 millimoles per liter (mmol/L)
Standard Deviation 3.22
|
10.62 millimoles per liter (mmol/L)
Standard Deviation 3.12
|
|
7-point Self-monitored Blood Glucose Profiles
Midday Postprandial Meal Baseline
|
12.77 millimoles per liter (mmol/L)
Standard Deviation 2.91
|
12.70 millimoles per liter (mmol/L)
Standard Deviation 3.36
|
|
7-point Self-monitored Blood Glucose Profiles
Morning Pre-Meal Week 16
|
7.04 millimoles per liter (mmol/L)
Standard Deviation 1.84
|
6.55 millimoles per liter (mmol/L)
Standard Deviation 1.67
|
|
7-point Self-monitored Blood Glucose Profiles
Morning Postprandial Meal Week 16
|
9.79 millimoles per liter (mmol/L)
Standard Deviation 2.74
|
9.55 millimoles per liter (mmol/L)
Standard Deviation 2.79
|
|
7-point Self-monitored Blood Glucose Profiles
Midday Pre-Meal Week 16
|
7.94 millimoles per liter (mmol/L)
Standard Deviation 2.37
|
7.64 millimoles per liter (mmol/L)
Standard Deviation 2.33
|
|
7-point Self-monitored Blood Glucose Profiles
Midday Postprandial Meal Week 16
|
10.13 millimoles per liter (mmol/L)
Standard Deviation 2.63
|
9.58 millimoles per liter (mmol/L)
Standard Deviation 2.65
|
|
7-point Self-monitored Blood Glucose Profiles
Evening Pre-Meal Week 16
|
8.52 millimoles per liter (mmol/L)
Standard Deviation 2.50
|
7.81 millimoles per liter (mmol/L)
Standard Deviation 2.46
|
|
7-point Self-monitored Blood Glucose Profiles
Evening Postprandial Meal Week 16
|
9.35 millimoles per liter (mmol/L)
Standard Deviation 2.73
|
9.80 millimoles per liter (mmol/L)
Standard Deviation 2.90
|
|
7-point Self-monitored Blood Glucose Profiles
0300 Hours Week 16
|
7.15 millimoles per liter (mmol/L)
Standard Deviation 2.09
|
7.01 millimoles per liter (mmol/L)
Standard Deviation 1.96
|
|
7-point Self-monitored Blood Glucose Profiles
Morning Pre-Meal Week 32
|
6.62 millimoles per liter (mmol/L)
Standard Deviation 1.55
|
6.21 millimoles per liter (mmol/L)
Standard Deviation 1.19
|
|
7-point Self-monitored Blood Glucose Profiles
Morning Postprandial Meal Week 32
|
8.80 millimoles per liter (mmol/L)
Standard Deviation 2.43
|
8.73 millimoles per liter (mmol/L)
Standard Deviation 2.09
|
|
7-point Self-monitored Blood Glucose Profiles
Midday Pre-Meal Week 32
|
6.93 millimoles per liter (mmol/L)
Standard Deviation 2.12
|
6.90 millimoles per liter (mmol/L)
Standard Deviation 1.76
|
|
7-point Self-monitored Blood Glucose Profiles
Midday Postprandial Meal Week 32
|
9.33 millimoles per liter (mmol/L)
Standard Deviation 2.49
|
8.86 millimoles per liter (mmol/L)
Standard Deviation 2.14
|
|
7-point Self-monitored Blood Glucose Profiles
Evening Pre-Meal Week 32
|
7.71 millimoles per liter (mmol/L)
Standard Deviation 2.18
|
7.50 millimoles per liter (mmol/L)
Standard Deviation 1.92
|
|
7-point Self-monitored Blood Glucose Profiles
Evening Postprandial Meal Week 32
|
8.62 millimoles per liter (mmol/L)
Standard Deviation 2.26
|
8.96 millimoles per liter (mmol/L)
Standard Deviation 2.31
|
|
7-point Self-monitored Blood Glucose Profiles
0300 Hours Week 32
|
6.63 millimoles per liter (mmol/L)
Standard Deviation 1.75
|
6.75 millimoles per liter (mmol/L)
Standard Deviation 1.73
|
|
7-point Self-monitored Blood Glucose Profiles
Morning Pre-Meal Week 48
|
6.74 millimoles per liter (mmol/L)
Standard Deviation 1.52
|
6.37 millimoles per liter (mmol/L)
Standard Deviation 1.17
|
|
7-point Self-monitored Blood Glucose Profiles
Morning Postprandial Meal Week 48
|
8.79 millimoles per liter (mmol/L)
Standard Deviation 2.28
|
8.85 millimoles per liter (mmol/L)
Standard Deviation 2.21
|
|
7-point Self-monitored Blood Glucose Profiles
Midday Pre-Meal Week 48
|
7.01 millimoles per liter (mmol/L)
Standard Deviation 1.99
|
6.99 millimoles per liter (mmol/L)
Standard Deviation 1.79
|
|
7-point Self-monitored Blood Glucose Profiles
Midday Postprandial Meal Week 48
|
9.25 millimoles per liter (mmol/L)
Standard Deviation 2.31
|
8.88 millimoles per liter (mmol/L)
Standard Deviation 2.31
|
|
7-point Self-monitored Blood Glucose Profiles
Evening Pre-Meal Week 48
|
7.33 millimoles per liter (mmol/L)
Standard Deviation 1.86
|
7.33 millimoles per liter (mmol/L)
Standard Deviation 2.03
|
|
7-point Self-monitored Blood Glucose Profiles
Evening Postprandial Meal Week 48
|
8.74 millimoles per liter (mmol/L)
Standard Deviation 2.11
|
8.90 millimoles per liter (mmol/L)
Standard Deviation 2.29
|
|
7-point Self-monitored Blood Glucose Profiles
0300 Hours Week 48
|
6.53 millimoles per liter (mmol/L)
Standard Deviation 1.54
|
6.56 millimoles per liter (mmol/L)
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Baseline, 16 weeks, 32 weeks, 48 weeksPopulation: Per-protocol set: randomized; no entry criteria violations; completed \>=32 weeks of study; no systemic glucocorticoid therapy \>14 cumulative days during study.
The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.
Outcome measures
| Measure |
Insulin Lispro LM
n=177 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=184 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Change From Baseline in Postprandial Blood Glucose Over Time
Week 16 Change from Baseline
|
3.32 millimoles per liter
Standard Error 1.16
|
3.55 millimoles per liter
Standard Error 1.17
|
|
Change From Baseline in Postprandial Blood Glucose Over Time
Week 32 Change from Baseline
|
4.69 millimoles per liter
Standard Error 1.19
|
4.56 millimoles per liter
Standard Error 1.18
|
|
Change From Baseline in Postprandial Blood Glucose Over Time
Week 48 Change from Baseline
|
5.24 millimoles per liter
Standard Error 1.20
|
4.89 millimoles per liter
Standard Error 1.20
|
SECONDARY outcome
Timeframe: 16 weeks, 32 weeks, 48 weeksPopulation: Full Analysis Set: all randomized patients who received at least one dose of study drug.
Outcome measures
| Measure |
Insulin Lispro LM
n=211 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=212 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks
Week 16
|
36.42 Units of insulin per day (U/day)
Standard Deviation 25.90
|
35.87 Units of insulin per day (U/day)
Standard Deviation 21.55
|
|
Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks
Week 32
|
50.38 Units of insulin per day (U/day)
Standard Deviation 34.02
|
48.16 Units of insulin per day (U/day)
Standard Deviation 31.18
|
|
Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks
Week 48
|
54.97 Units of insulin per day (U/day)
Standard Deviation 37.12
|
54.03 Units of insulin per day (U/day)
Standard Deviation 35.90
|
SECONDARY outcome
Timeframe: 16 weeks, 32 weeks, 48 weeksPopulation: Full Analysis Set: all randomized patients who received at least one dose of study drug.
Outcome measures
| Measure |
Insulin Lispro LM
n=211 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=212 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks
Week 16
|
0.49 Units of insulin/kilogram/day (U/kg/day)
Standard Deviation 0.36
|
0.49 Units of insulin/kilogram/day (U/kg/day)
Standard Deviation 0.29
|
|
Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks
Week 32
|
0.65 Units of insulin/kilogram/day (U/kg/day)
Standard Deviation 0.43
|
0.65 Units of insulin/kilogram/day (U/kg/day)
Standard Deviation 0.42
|
|
Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks
Week 48
|
0.71 Units of insulin/kilogram/day (U/kg/day)
Standard Deviation 0.45
|
0.71 Units of insulin/kilogram/day (U/kg/day)
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: baseline, 48 weeksPopulation: Full Analysis Set: all randomized participants who received at least one dose of study drug and had baseline and endpoint values.
Outcome measures
| Measure |
Insulin Lispro LM
n=211 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=212 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
High Density Lipoprotein (n=195, n=203)
|
0.06 millimoles/Liter (mmol/L)
Standard Error 0.05
|
0.04 millimoles/Liter (mmol/L)
Standard Error 0.05
|
|
Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
Cholesterol (n=195, n=203)
|
-0.18 millimoles/Liter (mmol/L)
Standard Error 0.18
|
-0.08 millimoles/Liter (mmol/L)
Standard Error 0.18
|
|
Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
Triglycerides (n=195, n=203)
|
-0.09 millimoles/Liter (mmol/L)
Standard Error 0.21
|
0.03 millimoles/Liter (mmol/L)
Standard Error 0.21
|
|
Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles
Low Density Lipoprotein (n=178, n=191)
|
-0.11 millimoles/Liter (mmol/L)
Standard Error 0.17
|
-0.06 millimoles/Liter (mmol/L)
Standard Error 0.17
|
SECONDARY outcome
Timeframe: baseline through 48 weeksPopulation: Full Analysis Set: all randomized participants who received at least one dose of study drug.
Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.
Outcome measures
| Measure |
Insulin Lispro LM
n=211 Participants
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=212 Participants
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Safety: Number of Participants With Serious and Non-Serious Adverse Events
Serious Adverse Events
|
19 participants
|
13 participants
|
|
Safety: Number of Participants With Serious and Non-Serious Adverse Events
Non-Serious Adverse Events
|
107 participants
|
116 participants
|
Adverse Events
Insulin Lispro LM
Serious events: 19 serious events
Other events: 107 other events
Deaths: 0 deaths
Insulin Glargine
Serious events: 13 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin Lispro LM
n=211 participants at risk
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=212 participants at risk
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.47%
1/211 • Number of events 1
|
0.47%
1/212 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.95%
2/211 • Number of events 2
|
0.00%
0/212
|
|
Cardiac disorders
Myocardial ischaemia
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Eye disorders
Vitreous haemorrhage
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Gastrointestinal disorders
Enteritis
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
General disorders
Cardiac death
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
General disorders
Influenza like illness
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
General disorders
Oedema peripheral
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Infections and infestations
Abscess limb
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
0.00%
0/211
|
0.94%
2/212 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.95%
2/211 • Number of events 2
|
0.00%
0/212
|
|
Injury, poisoning and procedural complications
Head injury
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.95%
2/211 • Number of events 2
|
0.00%
0/212
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Nervous system disorders
Brain stem infarction
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/211
|
0.47%
1/212 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
0.47%
1/211 • Number of events 1
|
0.00%
0/212
|
Other adverse events
| Measure |
Insulin Lispro LM
n=211 participants at risk
Insulin lispro low mixture (1, 2 or 3 daily injections)
|
Insulin Glargine
n=212 participants at risk
Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.95%
2/211 • Number of events 2
|
1.4%
3/212 • Number of events 3
|
|
Eye disorders
Cataract
|
1.9%
4/211 • Number of events 5
|
0.47%
1/212 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
5/211 • Number of events 7
|
2.4%
5/212 • Number of events 7
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
4/211 • Number of events 5
|
0.94%
2/212 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
1.9%
4/211 • Number of events 5
|
0.00%
0/212
|
|
Gastrointestinal disorders
Toothache
|
1.9%
4/211 • Number of events 4
|
0.94%
2/212 • Number of events 2
|
|
General disorders
Fatigue
|
1.9%
4/211 • Number of events 4
|
0.00%
0/212
|
|
General disorders
Oedema peripheral
|
4.7%
10/211 • Number of events 11
|
0.47%
1/212 • Number of events 1
|
|
General disorders
Pyrexia
|
1.9%
4/211 • Number of events 4
|
3.8%
8/212 • Number of events 8
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.4%
3/211 • Number of events 3
|
0.94%
2/212 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.95%
2/211 • Number of events 2
|
1.4%
3/212 • Number of events 3
|
|
Infections and infestations
Furuncle
|
0.47%
1/211 • Number of events 1
|
1.4%
3/212 • Number of events 3
|
|
Infections and infestations
Influenza
|
8.1%
17/211 • Number of events 24
|
10.4%
22/212 • Number of events 28
|
|
Infections and infestations
Localised infection
|
0.47%
1/211 • Number of events 1
|
1.9%
4/212 • Number of events 4
|
|
Infections and infestations
Lower respiratory tract infection
|
0.95%
2/211 • Number of events 2
|
1.9%
4/212 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
13/211 • Number of events 15
|
4.2%
9/212 • Number of events 11
|
|
Infections and infestations
Pharyngitis
|
1.9%
4/211 • Number of events 5
|
0.94%
2/212 • Number of events 2
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
3/211 • Number of events 4
|
0.94%
2/212 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
0.95%
2/211 • Number of events 2
|
1.4%
3/212 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
6/211 • Number of events 9
|
3.3%
7/212 • Number of events 9
|
|
Infections and infestations
Urinary tract infection
|
4.7%
10/211 • Number of events 11
|
4.7%
10/212 • Number of events 10
|
|
Infections and infestations
Viral infection
|
0.00%
0/211
|
1.4%
3/212 • Number of events 3
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.8%
8/211 • Number of events 8
|
1.9%
4/212 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.4%
3/211 • Number of events 3
|
1.9%
4/212 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.9%
4/211 • Number of events 4
|
0.47%
1/212 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.95%
2/211 • Number of events 4
|
2.4%
5/212 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.95%
2/211 • Number of events 2
|
2.4%
5/212 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/211
|
1.9%
4/212 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.4%
3/211 • Number of events 4
|
0.00%
0/212
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
6/211 • Number of events 7
|
3.8%
8/212 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.4%
3/211 • Number of events 3
|
0.00%
0/212
|
|
Nervous system disorders
Dizziness
|
1.4%
3/211 • Number of events 4
|
1.9%
4/212 • Number of events 4
|
|
Nervous system disorders
Headache
|
3.8%
8/211 • Number of events 14
|
1.4%
3/212 • Number of events 4
|
|
Nervous system disorders
Sciatica
|
1.4%
3/211 • Number of events 3
|
0.47%
1/212 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/211
|
1.4%
3/212 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
4/211 • Number of events 4
|
1.4%
3/212 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
4/211 • Number of events 4
|
3.8%
8/212 • Number of events 8
|
|
Vascular disorders
Hypertension
|
3.8%
8/211 • Number of events 8
|
4.2%
9/212 • Number of events 9
|
|
Vascular disorders
Venous insufficiency
|
0.95%
2/211 • Number of events 2
|
1.4%
3/212 • Number of events 3
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60